Page 124 - Drug Class Review
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Page 92 of 205
Drug Effectiveness Review Project
To directly compare the effectiveness and tolerability of DON and GAL in the treatment of AD and
investigate effects of both treatments on cognition and activities of daily living
galantamine 4-12 mg twice daily 12 weeks 56 At least 50 years of age diagnosed with probable or possible mild to moderate AD consistent with NINCDS/ADRDA and DSM-IV criteria; MMSE score at screening within range 10-24 inclusive; results of CT or MRI scan within past 18 months consistent with AD diagnosis; availability of caregiver to Previous treatment with ChE inhibitor or with known hypersensitivity to ChE inhibitors; clinically significant obstructive pulmonary disease, asthma, gastrointestinal, endocrine, or cardiovascular disease; known sensit
Drugs Authors: Jones et al. 28 Country: Multinational (UK, Finland, Germany, Norway) Study design: RCT (open-label) Setting: Multi-center (14 centers ) donepezil 5-10 mg once daily 12 weeks 64 provide information on patient’s status and ensure compliance
Alzheimer Year: 2004 Eisai Inc., Pfizer Inc. Sample size: 120 NR
Final Report Update 1 Efficacy/Effectiveness STUDY: FUNDING: RESEARCH OBJECTIVE: DESIGN: INTERVENTION: Dose: Duration: Sample size: INCLUSION: EXCLUSION: OTHER MEDICATIONS/ INTERVENTIONS ALLOWED: Alzheimer's Drugs